Quest Diagnostics has received emergency use authorization from FDA to use specimen pooling with its molecular diagnostic test for COVID-19 as the virus rates in some parts of the U.S. surge.
The Secaucus, N.J.-based company said it is the first lab provider to gain EUA for this technique.
In pooling, specimens must still be collected into individual vials, but then are combined into small batches or pools by the laboratory. A negative result for a batch means that all patients in that pool are considered negative If a positive result occurs for the batch, each specimen is retested individually.
Pooling is used routinely in blood banking to screen donated blood for a variety of viruses, among other applications.
The firm said it expects to deploy the technique at its laboratories in Chantilly, VA and Marlborough, MA., by the end of next week with additional laboratories to follow.
Jay Wohlgemuth, MD, Senior Vice President and CMO, Quest Diagnostics, said in a release, “Pooling will help expand testing capacity, but it is not a magic bullet, and testing times will continue to be strained as long as soaring COVID-19 test demand outpaces capacity. Each of us can practice behaviors that will reduce COVID-19 infections in our communities, so our national healthcare system can better respond to this crisis.”
Luminex Joins Quest in Receiving EUA
Quest wasn't the only company on Monday to report it had EUA. FDA also doled out the authorization to Luminex for the xMAP SARS-CoV-2 Multi-Antigen IgG Assay.
The Austin, TX-based company said the xMAP SARS-CoV-2 Multi-Antigen IgG assay is designed to simultaneously detect antibodies against three antigens and delivers results for up to 96 patient samples in under three hours.
This is the third COVID-19 Luminex test to receive EUA, joining the NxTAG CoV Extended Panel and the Aries SARS-CoV-2 Assay.
"More than 17,000 xMAP systems have been sold to laboratories around the world, and this FDA authorization creates important new opportunities for these labs to rapidly expand their COVID-19 testing capabilities with a highly accurate serology-based assay," Nachum "Homi" Shamir, president and CEO of Luminex said in a release. "In close collaboration with our extensive network of partners and customers, Luminex continues to be on the frontlines in the mission-critical effort to address the current pandemic with state-of-the-art testing and innovative technologies such as xMAP."
Much Has Changed Since Quest’s First COVID-19 EUA
Quest joined the coronavirus-detection fight in early March when it launched its COVID-19 test service that aids in the presumptive detection of nucleic acid in respiratory specimens of patients meeting Centers for Disease Control and Prevention clinical criteria.
When Quest made the March announcement of its testing service CDC was reporting there were at least 129 confirmed COVID-19 cases and at least 11 deaths in the U.S. Today, there are about 3.9 million cases in the U.S., with 143,455 deaths and about 1.8 million recovering according to data from www.worldometers.info.